TORQR SERIES DIAGNOSTIC EP CATHETERS— 510(k) K923915

Name: FDA 510(k) clearance K923915
Creator: U.S. Food and Drug Administration
Published: 1993-02-10

Substantially Equivalent

Cardiorhythm

FDA 510(k) clearance K923915 for TORQR SERIES DIAGNOSTIC EP CATHETERS, Substantially Equivalent on 1993-02-10. Applicant: Cardiorhythm. Device class: 2.

Clearance details

Applicant: Cardiorhythm
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1992-07-21
Decision date: 1993-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRF

view all

K252794 — Vision-MR Diagnostic Catheter2026-01-08
K250590 — MAGiC Sweep EP Mapping Catheter2025-07-23
K250310 — VIKING Fixed Curve Diagnostic Catheter2025-06-27
K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more2024-11-01
K233900 — Nordica PV Cryo Mapping Catheter2024-09-06

More clearances from Cardiorhythm

view all

K923916 — VOYAGR SERIES DIAGNOSTIC EP CATHETERS1993-02-10

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.